[A22-51] Abemaciclib (breast cancer) – Benefit assessment according to §35a Social Code Book V

Last updated 20.10.2022

Project no.:
A22-51

Commission:
Commission awarded on 29.04.2022 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Cancer

Indication:

Adjuvant treatment of patients with HR-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence

Result of dossier assessment:
  • Premenopausal women: hint of minor added benefit
  • Postmenopausal women: added benefit not proven
  • Men: added benefit not proven
Note:

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.

The current version 1.1 of the dossier assessment replaces version 1.0 published on 2022-10-10.

Federal Joint Committee (G-BA)

2022-10-20 A G-BA decision was published.

G-BA documents on this decision

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